Trunk and Upper Extremities Program Effect in Decreasing Compensation Patterns in Unilateral Cerebral Palsy Children

Chronic Pain Clinical Trial

— TUPEX  

Official title:

Trunk and Upper Extremities Program Effect in Decreasing Compensation Patterns in Unilateral Cerebral Palsy Children: Randomized Control Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06069765
• Other study ID #: TrunkUpperExtremityPrograma
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: July 2026

Study information

• Verified date: September 2023
• Source: Fundacio Aspace Catalunya
• Contact: Georgina Domenech Garcia
• Phone: +34 656707865
• Email: gdomenech[@]uic.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to test the effectiveness of a trunk and upper extremities exercise program. The main questions it aims to answer are:

Whether the program decreases compensation patterns in unilateral cerebral palsy children Whether the program decreases pain in unilateral cerebral palsy children Whether the program improves bimanual ability in unilateral cerebral palsy children Participants will undertake and 8-week program exercise at home If there is a comparison group: Researchers will compare with the control group to see if this program decreases compensation patterns.

Description:

Children in control group will continue with their daily activities. Children in experimental group, apart from their daily activities, will undertake an 8-week program exercise at home for strengthening the trunk and the proximal part of both upper extremities. It contains 3 progressions that can be applied if needed.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

Inclusion Criteria:

• Unilateral cerebral palsy diagnostic

• Level I or II of the Manual Ability Scale Classification

Exclusion Criteria:

• Have received any intervention with botulinum toxin or shock waves in the previous six months or have them scheduled during the intervention

• Are undergoing treatment with intensive therapies.

• To have known alteration in the hips

• Have very serious attention or comprehension difficulties that prevent them from following instructions.

• Suffer uncontrolled epilepsies

• Suffer from severe visual problems.

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy Infantile
• Chronic Pain
• Paralysis
• Upper Extremity Dysfunction

Intervention

Other:
• TUPEX
This program contains exercises with their own body weight or with Thera-bands for gaining strength in their shoulder and trunk muscles. It contains some progression exercise if needed. Each session can last between 20 and 30 minutes. Children have to do each session three times a week during 8 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Fundacio Aspace Catalunya	Universitat Internacional de Catalunya

References & Publications (6)

Abd-Elfattah HM, Aly SM. Effect of Core Stability Exercises on Hand Functions in Children With Hemiplegic Cerebral Palsy. Ann Rehabil Med. 2021 Feb;45(1):71-78. doi: 10.5535/arm.20124. Epub 2021 Feb 9. — View Citation

Brochard S, Lempereur M, Mao L, Remy-Neris O. The role of the scapulo-thoracic and gleno-humeral joints in upper-limb motion in children with hemiplegic cerebral palsy. Clin Biomech (Bristol, Avon). 2012 Aug;27(7):652-60. doi: 10.1016/j.clinbiomech.2012.0 — View Citation

Francisco-Martinez C, Prado-Olivarez J, Padilla-Medina JA, Diaz-Carmona J, Perez-Pinal FJ, Barranco-Gutierrez AI, Martinez-Nolasco JJ. Upper Limb Movement Measurement Systems for Cerebral Palsy: A Systematic Literature Review. Sensors (Basel). 2021 Nov 26 — View Citation

Jackman M, Sakzewski L, Morgan C, Boyd RN, Brennan SE, Langdon K, Toovey RAM, Greaves S, Thorley M, Novak I. Interventions to improve physical function for children and young people with cerebral palsy: international clinical practice guideline. Dev Med C — View Citation

Mckinnon CT, Meehan EM, Harvey AR, Antolovich GC, Morgan PE. Prevalence and characteristics of pain in children and young adults with cerebral palsy: a systematic review. Dev Med Child Neurol. 2019 Mar;61(3):305-314. doi: 10.1111/dmcn.14111. Epub 2018 Dec — View Citation

Novak I. Evidence-based diagnosis, health care, and rehabilitation for children with cerebral palsy. J Child Neurol. 2014 Aug;29(8):1141-56. doi: 10.1177/0883073814535503. Epub 2014 Jun 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of variance of the Compensation patterns	DeepLabCut (DLC) (Artificial Intelligence). Calculate the kinematic difference of the body marks during the activities	8 weeks
Secondary	Intensity of pain	Face Pain Scale - Revised (FPS-R). The face marked is compared before and after the treatment. 0 is the minimum scores, meaning no pain, and 10 is the maximum score, meaning really severe pain.	8 weeks
Secondary	Location of pain	In the Body Diagram. The location of the pain is compared before and after the treatment	8 weeks
Secondary	Bimanual ability	Children Hand-Use Experience Questionaire 2.0 (CHEQ 2.0). Whether they are more capable of doing more bimanual activities or not. The maximum score in each question is 100 and the minimum is 0. 100 means children use their hands like the neurotypical children, and 0 means they can't use the affected hand at all.	8 weeks